{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "193331",
      "product_res_number": "Z-1102-2022",
      "event_date_initiated": "2022-03-30",
      "event_date_created": "2022-05-17",
      "recall_status": "Open, Classified",
      "res_event_number": "90079",
      "product_code": "DSQ",
      "pma_numbers": [
        "P100047"
      ],
      "product_description": "HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104",
      "code_info": "GTIN 00888707000598, Serial Numbers:  HW28827  GTIN 00888707001649, Serial Numbers:  HW29474, HW29864, HW29985, HW30222, HW31506, HW31511, HW32021, HW32255, HW32301, HW34343, HW35068, HW35085, HW35290, HW35311, HW35349, HW35559, HW35657, HW35662, HW35664  GTIN 00888707002424, Serial Numbers:  HW29480, HW29696, HW30650, HW30766, HW30767,  HW31698, HW31851  GTIN 00888707004558, Serial Numbers:  HW34759, HW34785, HW35655, HW35656  GTIN 00888707006323, Serial Numbers:  HW34982, HW35722, HW36082, HW36189, HW36297, HW36375, HW36452, HW36539, HW36605, HW36649, HW36687, HW36740, HW36798, HW36865, HW37202\t  GTIN 00888707005951, Serial Numbers:  HW35887, HW35893  GTIN 00888707006347, Serial Numbers:  HW36040, HW36048, HW36049, HW36050, HW36051, HW36052, HW36053, HW36054, HW36055, HW36088, HW36089, HW36092, HW36093, HW36094, HW36095, HW36096, HW36097, HW36100, HW36101, HW36102, HW36103, HW36105, HW36106, HW36107, HW36108, HW36109, HW36110, HW36111, HW36112, HW36170, HW36540, HW36541, HW36542, HW36543, HW36544, HW36565, HW36566, HW36568, HW36569, HW36570, HW36571, HW36572, HW36573, HW36574, HW36575, HW36576, HW36577, HW36578, HW36579, HW36581, HW36582, HW36583, HW36584, HW36585, HW36586, HW36611, HW36612, HW36615, HW36616, HW36618, HW36619, HW36620, HW36621, HW36622, HW36623, HW36808, HW36809, HW36810, HW36918, HW36946, HW36948, HW36949, HW36950, HW36951, HW36952, HW36953, HW36954, HW36955, HW36956, HW36959, HW36960, HW36961, HW36962, HW36963, HW37006, HW37007, HW37008, HW37009, HW37010, HW37154, HW37155, HW37156, HW37157, HW37161, HW37162, HW37164, HW37165, HW37166, HW37168, HW37169, HW37263, HW37358, HW37378, HW37381, HW37386, HW37387, HW37432, HW37434, HW37440, HW37447\t  GTIN 00888707003209, Serial Numbers:  HW41915, HW41916, HW41918, HW41919, HW41945, HW41946, HW41947, HW41948, HW41978, HW41979, HW41981, HW41982, HW41983, HW41984, HW41988, HW41990\t\t  GTIN 00888707002486, Serial Numbers:  HW30860, HW30835, HW30807, HW30817, HW30861, hw30795, hw30800, HW30663, hw30794, HW30662, hw30793, HW30664, hw30799, HW30516, hw30798, HW30514, HW30522, HW30518, HW30517, HW30391, HW30361, HW30401, HW30362, HW30396, HW30405, HW30395, HW30389, HW30394, HW30359, HW30141, HW30142, HW30140, HW30135, HW30143, HW30136, HW30144, HW30139, HW30137, HW29759, HW29762, HW29758, HW29765, HW29760, HW29757, HW29770, HW29771, HW29768, HW29769, HW29795, HW29747, HW29752, HW29734, HW29750, HW29749, HW29746, HW29748, HW29025, HW29432, HW29442, HW29446, HW29344, HW29482",
      "firm_fei_number": "3007042319",
      "recalling_firm": "Heartware, Inc.",
      "address_1": "14400 Nw 60th Ave",
      "city": "Miami Lakes",
      "state": "FL",
      "postal_code": "33014-2807",
      "additional_info_contact": "MCS Customer Service\n877-367-4823",
      "reason_for_recall": "Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.",
      "root_cause_description": "Labeling design",
      "action": "Starting 30-Mar-2022, Medtronic initiated an Urgent Medical Device Notice to VAD Coordinators at customer sites by regional mail and visit in order to inform them of the errors and the corrections impacting the incorrect translation in Finland and Turkey for the HVAD\" System. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients of the issues to the Patient Manual.",
      "product_quantity": "236 units",
      "distribution_pattern": "Finland and Turkey",
      "openfda": {
        "pma_number": [
          "P100047",
          "P980012",
          "P870072",
          "P920014",
          "P900023",
          "P160035",
          "P160054",
          "P060040",
          "P170038"
        ],
        "registration_number": [
          "1319639",
          "2182208",
          "3008454189",
          "3011823740",
          "3019807891",
          "1218444",
          "3004582654",
          "1927395",
          "1721676",
          "2916596",
          "3005228872",
          "9612515",
          "3007042319",
          "3002807090",
          "3008792657",
          "2133810",
          "2031044",
          "3012931014",
          "2134470",
          "2528981",
          "2029275",
          "3003306248",
          "3010163695"
        ],
        "fei_number": [
          "1000138054",
          "3001236763",
          "2182208",
          "3008454189",
          "3011823740",
          "3019807891",
          "1218444",
          "3006003617",
          "3004582654",
          "1927395",
          "1721676",
          "2916596",
          "3002462840",
          "3005228872",
          "1000306431",
          "3007042319",
          "3002808437",
          "3008792657",
          "3012931014",
          "2528981",
          "3000203066",
          "3003306248",
          "3010163695"
        ],
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}